drugset / Trial / NCT04465383
Digital Sedation: Virtual Reality Hypnosis During Colonoscopy
RandomizedParallel-groupOpen-labelSupportive care
Summary
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.
Timeline
- Start
- 2020-06-25
- Primary completion
- 2021-09-20
- Completion
- 2021-12-21
Outcome
Outcome not reported
Stopped (Enrollment): “Recruitment too complicated during pandemics. Phase 2 of recruitment completed and enough data available.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Propofol | Small molecule | 1 ug/ml | Intravenous |
| Subject | Propofol | Small molecule | 6 ug/ml | Intravenous |
Indications
No indication recorded.